Device product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Z-1952-2012
Product summary
- Event
- Event 61793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 221 kits
- Official record key
device-enforcement:Z-1952-2012
Official wording
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Code information: Lot numbers M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, and M840810.
Distribution pattern: Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
Derived failure modes
-
Unknown
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.